Combination of a taxane and a cyclin-dependent kinase

Abstract

The invention relates to a pharmaceutical combination comprised of paclitaxel (Taxol®), docetaxel (Taxotere®), or derivatives of them, and a cyclin-dependent kinase inhibitor. It also relates to a method of administration of such a combination, where the taxane is given intermittently and the cyclin-dependent kinase is given repeatedly within the same cycle.

What is claimed is:  
     
         1 . A combination comprising: a) paclitaxel, docetaxel, or one or more derivatives thereof, and b) at least one of: L-asparaginase, a cyclin-dependent kinase inhibitor, a biological response modifier, and a growth factor inhibitor.  
     
     
         2 . The combination of  claim 1 , wherein said combination comprises paclitaxel.  
     
     
         3 . The combination of  claim 1 , wherein said combination comprises docetaxel.  
     
     
         4 . The combination of  claim 1 , wherein said combination comprises L-asparaginase.  
     
     
         5 . The combination of  claim 1 , wherein said combination comprises a cyclin dependent kinase inhibitor.  
     
     
         6 . The combination of  claim 5 , wherein said cyclin dependent kinase inhibitor is flavopiridol.  
     
     
         7 . The combination of  claim 5 , wherein said cyclin de pendent kinase inhibitor is quercitin or genistein.  
     
     
         8 . The combination of  claim 1 , comprising docetaxel and flavopiridol.  
     
     
         9 . The combination of  claim 1 , wherein the combination is a single composition.  
     
     
         10 . A pharmaceutical combination comprising: a) paclitaxel, docetaxel, or one or more derivatives thereof, and b) a cyclin-dependent kinase inhibitor, in amounts sufficient to provide therapeutic synergy in the treatment of at least one neoplastic disease.  
     
     
         11 . The pharmaceutical combination of  claim 10 , wherein the neoplastic disease is breast cancer.  
     
     
         12 . The pharmaceutical combination of  claim 10 , wherein the neoplastic disease is lung cancer.  
     
     
         13 . The pharmaceutical combination of  claim 10 , wherein said combination comprises paclitaxel.  
     
     
         14 . The pharmaceutical composition of  claim 10 , wherein said combination comprises docetaxel.  
     
     
         15 . The pharmaceutical combination of  claim 10 , wherein said cyclin-dependent kinase inhibitor is flavopiridol.  
     
     
         16 . A method of treating a neoplastic disease, said method comprising administering a combination comprising the following components: 
 a) paclitaxel, docetaxel, or one or more derivatives thereof, and    b) a cyclin-dependent kinase inhibitor, a biological response modifier, to a subject in an amount sufficient to treat said neoplastic disease.    
     
     
         17 . The method of  claim 16 , wherein said components are administered separately.  
     
     
         18 . The method of  claim 17 , wherein said components are administered at different times.  
     
     
         19 . The method of  claim 17 , wherein the neoplastic disease is breast cancer.  
     
     
         20 . The method of  claim 17 , wherein the neoplastic disease is lung cancer.  
     
     
         21 . The method of  claim 17 , wherein said cyclin dependent kinase inhibitor is flavopiridol.  
     
     
         22 . The method of  claim 21 , wherein said flavopiridol is administered orally.  
     
     
         23 . The method of  claim 17 , wherein the combination comprises docetaxel and flavopiridol.  
     
     
         24 . The method of  claim 23 , wherein the method comprises a ten day treatment cycle in which docetaxel is administered on the first and last days and flavopiridol is administered on the first four days and last four days of said ten day cycle.  
     
     
         25 . The method of  claim 23 , wherein the method comprises a 23 day treatment cycle in which docetaxel is administered on days 14 and 23 and flavopiridol is administered on days 14 through 17 and days 20 through 23.  
     
     
         26 . The method of  claim 23 , wherein the method comprises a 25 day treatment cycle in which docetaxel is administered on days 14 and 25 and flavopiridol is administered orally on days 14 through 18 and days 21 through 25.